COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study

University of Sao Paulo40 enrolled

Overview

This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the number of oocytes retrieved.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility

Interventions

COOL-COSDRUG

Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: Oral clomiphene citrate: 100 mg/day until the day of the triggering. Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation. Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation. The triggering will be performed using leuprorelin 1 mg (subcutaneous).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women scheduled to controlled ovarian stimulation for oocyte retrieval. * Body mass index between 18 and 35 Kg/m2. * Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle \>10mm and serum estradiol ≥ 40 pg/L). * Signing an informed consent. Exclusion Criteria: * None

Locations (1)

Setor de Reprodução Humana - HC-FMRP-USP

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

Number of oocytes retrieved

Time frame: 20 days

Secondary Outcomes

Number of embryos

Time frame: 25 days

Ovarian hyperstimulation syndrome

Time frame: 2 months

Data from ClinicalTrials.gov

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